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Expedited Access for Premarket Approval and De Novo Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions - Guidance for Industry and Food and Drug Administration Staff

FDA-EXPEDITED-ACCESS - 2014 DRAFT - SUPERSEDED
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Expedited Access for Premarket Approval and De Novo Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions - Guidance for Industry and Food and Drug Administration Staff


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Document Number

FDA-EXPEDITED-ACCESS

Revision Level

2014 DRAFT

Status

Superseded

Publication Date

April 23, 2014

Page Count

35 pages